NCT03262870

Brief Summary

Gut microbiota and multiple sclerosis Multiple sclerosis is a pro-inflammatory demyelinating disease of the central nervous system.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 4, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2020

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 24, 2017

Last Update Submit

August 27, 2017

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Understanding the role of gut microbiota in the modification of the disease course of MS .

    24 month

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients admitted in Assiut University hospital and outpatient clinic individuals

You may qualify if:

  • The study will included 40 cases of MS according to Diagnostic criteria of multiple sclerosis they classified into two types of Multiple sclerosis ,Relapsing-remitting MS (group 1), and Primary progressive MS, Secondary progressive MS, and Progressive relapsing MS (group 2).
  • Each patient was submitted to the following:
  • Expanded disability status scale score between 1 and 6 and functional system score.
  • Demographic and clinical data (Age, sex, age of onset, severity of disease, clinical symptoms and signs, Types of treatment, duration of treatment, number of attacks).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Eman Khadr, Professor

CONTACT

01005850632Emankhadr99@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 25, 2017

Study Start

January 4, 2018

Primary Completion

January 4, 2019

Study Completion

January 4, 2020

Last Updated

August 29, 2017

Record last verified: 2017-08